Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 579 for:    Taste Disorders AND taste

Metallic Taste Before, During and After Treatment of Head and Neck Cancer (TORCAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03558789
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de Valence

Brief Summary:

Metallic taste in head and neck cancer is widely under-estimated in the literature. Its causes are multiple and poorly defined. Though it has a strong impact on the nutritional status.

The main objective of the TORCAD project is to test the hypothesis that intraoral lipoperoxidation is associated to metallic taste onset before, during and after treatment of head and neck cancer (HNC).

The secondary goals are to evaluate the involvement of others physiopathological factors in metallic taste: (i) additional chemical modification in the saliva; (ii) release of inhibition of the facial nerve on the glossopharyngeal nerve; presence of an intraoral electric current; food pleasantness and acceptability; quality of life.


Condition or disease Intervention/treatment
Metallic Taste Biological: bovine lactoferrin

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Metallic Taste Before, During and After Treatment of Head and Neck Cancer : Etiologies and Impact on Quality of Life
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MT
patients complaining about metallic taste before, during or after treatment of head and neck cancer.
Biological: bovine lactoferrin
mouthwash

No-MT
patients not complaining about metallic taste before, during or after treatment of head and neck cancer.
Biological: bovine lactoferrin
mouthwash




Primary Outcome Measures :
  1. Change from Baseline salivary malondialdehyde level within one year after treatment completion [ Time Frame: Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0 ]
    The lipoperoxidation will be measured with salivary dosage of malondialdehyde (µmol/L). As metallic taste may vary according time, the measure will be repeated.


Secondary Outcome Measures :
  1. Change from Baseline métabolites levels modifications of the saliva within one year after treatment completion [ Time Frame: Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0 ]
    Additional chemical modifications of the saliva will be tested by salivary dosages: uric acid in µmol/ml

  2. Change from Baseline ions levels modifications of the saliva within one year after treatment completion [ Time Frame: Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0 ]
    Additional chemical modifications of the saliva will be tested by salivary dosages: Mn2+ and Zn2+, in µmol/ml

  3. Change from Baseline enzymes levels modifications of the saliva within one year after treatment completion [ Time Frame: Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0 ]
    Additional chemical modifications of the saliva will be tested by salivary dosages: peroxydase, catalase, superoxide dismutase (in IU/ml)

  4. Change from Baseline fungiform papillae density of the tonguewithin one year after treatment completion [ Time Frame: Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0 ]
    fungiform papillae density before, during and after treatment will be measured by tongue dermatoscopy. As metallic taste may vary according time, the measure will be repeated.

  5. release of inhibition of the facial nerve on the glossopharyngeal nerve [ Time Frame: Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0 ]
    The release of inhibition of the facial nerve on the glossopharyngeal nerve will be tested with taste and smell psychophysical tests (supraliminory intensity taste testing and European Tests of Olfactory Capabilities) and a metallic taste-specific questionnaire [IJpma et al. Metallic Taste in Cancer Patients Treated with Systemic Therapy: A Questionnaire-based Study. Cancer Nutr 2017]. As metallic taste may vary according time, the measure will be repeated.

  6. change from Baseline intraoral electric current within one year after treatment completion [ Time Frame: Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0 ]
    the presence of an intraoral electric current will be tested by impedancemetry. As metallic taste may vary according time, the measure will be repeated.

  7. Change frome Baseline quality of life within one year after treatment completion [ Time Frame: Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0 ]
    questionnaires (EORTC QLQ30 and HN35). As quality of life may vary according time, the measure will be repeated.

  8. Change frome Baseline food pleasantness and acceptability within one year after treatment completion [ Time Frame: Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0 ]
    questionnaires (IJpma el al. Nutrition and cancer. 2017;69:140-5) and an analogic visual scale of dietary intakes (from 1 to 10, from Thibault R et al. Clin Nutr. 2009;28:134-40). As metallic taste may vary according time, the measure will be repeated.


Biospecimen Retention:   Samples Without DNA
saliva samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 patients with head and neck cancer before any treatment will be recruited. Repartition between the two groups will be performed a posteriori after onset or not of the metallic taste perception.
Criteria

Inclusion Criteria:

  • Any head and neck cancer
  • Before any treatment and treatment (surgery, chemotherapy, radiation therapy)
  • Before the appearance of the metallic taste symptom
  • Age ≥ 18 years
  • Estimated life expectancy ≥ 6 months.
  • Affiliation to a Social security system
  • Patient who has given written consent signed before any specific procedure of the protocol

Exclusion Criteria:

  • History of cancer (head and neck or other) that could be a confounding factor (dysgeusia, dysosmia, salivary composition disorder)
  • Pregnant woman (frequent dysgeusia and dysosmia)
  • Total laryngectomy (treatment-induced hyposmia)
  • Early cancer recurrence (< 6 months after the end of the last treatment) because the taste, smell, and/or composition of the saliva can be altered by the cancer itself
  • Persons deprived of liberty, under guardianship or under curatorship or unable to submit to the medical follow-up of the test for geographical, social or psychic reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558789


Contacts
Layout table for location contacts
Contact: guillaume buiret, MD +33475757528 gbuiret@ch-valence.fr
Contact: sandrine beauchard sbeauchard@ch-valence.fr

Locations
Layout table for location information
France
CH Valence Recruiting
Valence, France, 26953
Contact: Guillaume Buiret, MD    +475757528    gbuiret@ch-valence.fr   
Contact: Sandrine Beauchard       sbeauchard@ch-valence.fr   
Principal Investigator: guillaume buiret, MD         
Sponsors and Collaborators
Centre Hospitalier de Valence
Investigators
Layout table for investigator information
Study Director: Gilles Feron, PhD Centre des Sciences du Goût et de l'Alimentation

Layout table for additonal information
Responsible Party: Centre Hospitalier de Valence
ClinicalTrials.gov Identifier: NCT03558789     History of Changes
Other Study ID Numbers: 00001
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Taste Disorders
Neoplasms by Site
Neoplasms
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lactoferrin
Anti-Infective Agents